Unresectable Locally Advanced Pancreatic CancerNCT06844773
Chemoradiotherapy in Elderly Patients with Locally Advanced Pancreatic Cancer (70+).
An observational study of Unresectable Locally Advanced Pancreatic Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The goal of this observational study is to learn about the therapeutic effects of chemoradiotherapy for older adults (age 70-85) with locally advanced pancreatic cancer. The main question it aims to answer is: Does chemoradiotherapy represent an effective and safe treatment for older participants without radical… Read more about this study
- Who is it for?
- Ages 70 to 85 years
- Conditions the study is for
- Unresectable Locally Advanced Pancreatic Cancer
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Feb 2025to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients with locally advanced pancreatic cancer who are evaluated by imaging at Shanghai Zhongshan hospital, aged between 70 and 85 years old, will be screened and enrolled after discussion by the ZSPAC multidisciplinary expert committee.
Who may be able to join
- Voluntarily participate and sign the informed consent form
- Age 70-85 years old, life expectancy > 1 year and gender is not limited
- Eastern Cooperative Oncology Group Physical Status Score (ECOG) physical state score<=1 point
- Pathological or cytological confirmation of pancreatic ductal adenocarcinoma (including IPMN malignant transformation, acinar carcinoma, etc., excluding adenosquamous cell carcinoma and neuroendocrine carcinoma)
- The clinical stage is stage III (locally advanced pancreatic cancer), and no radical surgery has been performed (bypass surgery is acceptable), or the patient has resectable pancreatic cancer, but cannot accept surgery or refuse surgery due to physical strength or concomitant diseases
- Have not received any form of anti-tumor therapy before treatment, including systemic chemotherapy, interventional chemotherapy, high-energy focused ultrasound, radiotherapy, immunotherapy, molecular targeted therapy, and anti-tumor traditional Chinese medicine therapy
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- No serious hematological, cardiological, pulmonary function abnormalities and autoimmune deficiencies (refer to their respective diagnostic criteria)
- Blood routine index: white blood cell (WBC) >=3.0 × 109/L; Absolute neutrophil count (ANC) >=1.5 × 109/L; Platelets (PLT) >=100 × 109/L; hemoglobin (Hgb) >=90 g/L
- Blood biochemical indexes: AST (SGOT), ALT (SGPT) <=2.5 × upper limit of normal value (ULN); Total bilirubin (TBIL) < = ULN; Serum creatinine (CRE) <=1.5 × ULN
- Coagulation function: prothrombin time (PT), international normalized ratio (INR) <=1.5 × ULN
- Able to comply with the requirements of the study visit plan and other programs.
Who cannot join
- Accompanied by malignant tumors of other systems
- Received any form of anti-tumor therapy before treatment, including systemic chemotherapy, interventional chemotherapy, high-energy focused ultrasound, radiotherapy, immunotherapy, molecular targeted therapy, and anti-tumor traditional Chinese medicine therapy
- Have used any other non-anti-tumor research drugs within 4 weeks before treatment
- Combined with uncontrollable hypertension, diabetes, infection, etc.
- Poor compliance, unable or unwilling to sign informed consent
- Patients who are expected to be out of the observation period for 14 days or more during the treatment period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital
Shanghai
Wen-Quan Wang Wang, wang.wenquan@zs-hospital.sh.cn
About this study
Official title: A Single-center, Prospective, Observational Cohort Study of Chemoradiotherapy in Elderly Patients with Locally Advanced Pancreatic Cancer (70+).
The goal of this observational study is to learn about the therapeutic effects of chemoradiotherapy for older adults (age 70-85) with locally advanced pancreatic cancer. The main question it aims to answer is:
Does chemoradiotherapy represent an effective and safe treatment for older participants without radical surgery? Participants will sequentially receive combined chemotherapy followed by concurrent chemoradiotherapy and subsequent maintenance therapy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year survival rate
To observe whether the 1-year survival rate of elderly patients with locally advanced pancreatic cancer treated with sandwich-like chemoradiotherapy modality was comparable to that of the historical data of the general adult population.
Measured: From the date of first therapy administration to one year later
Secondary outcomes (6)
Toxicity and side effects and tolerability assessment
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTCAE Version 5.0.
Measured: From the date of first therapy administration to within 90 days, up to 24 months
event-free survival throughout the enrolled subject population
Survival time from the start of therapy administration to the date of first documented progression or the date of death
Measured: From the date of first therapy administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
the proportion of participants that completed chemoradiotherapy
Measured: From the date of first enrollment to the date of completion of follow-up of the last patient, up to 24 months.
the proportion ofparticipants that completed all planned courses
Measured: From the date of first enrollment to the date of completion of follow-up of the last patient, up to 24 months.
Objective response rate (ORR) tumor target lesions in the entire subject population all planned courses
ORR is defined as the percentage of patients who achieve complete response (CR) or partial response (PR) based on the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
Measured: From the date of first therapy administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Disease control rate (DCR) of tumor target lesions in the entire subject population all planned courses
DCR is defined as the percentage of patients who achieved CR, PR and stable disease (SD), and will be evaluated based on RECIST 1.1 and the irRECIST criteria.
Measured: From date of first therapy administration until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Locally Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844773
- Sponsor's protocol ID
- ZSPAC-08
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Prospective, Observational Cohort Study of Chemoradiotherapy in Elderly Patients with Locally Advanced Pancreatic Cancer (70+).
- ClinicalTrials.gov ID
- NCT06844773
- Acronym / sponsor ID
- ZSPAC-08
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the therapeutic effects of chemoradiotherapy for older adults (age 70-85) with locally advanced pancreatic cancer. The main question it aims to answer is:
Does chemoradiotherapy represent an effective and safe treatment for older participants without radical surgery? Participants will sequentially receive combined chemotherapy followed by concurrent chemoradiotherapy and subsequent maintenance therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | – |
Who may qualify
- Ages
- 70 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients with locally advanced pancreatic cancer who are evaluated by imaging at Shanghai Zhongshan hospital, aged between 70 and 85 years old, will be screened and enrolled after discussion by the ZSPAC multidisciplinary expert committee.
Key inclusion criteria (11 listed)
- Voluntarily participate and sign the informed consent form
- Age 70-85 years old, life expectancy > 1 year and gender is not limited
- Eastern Cooperative Oncology Group Physical Status Score (ECOG) physical state score<=1 point
- Pathological or cytological confirmation of pancreatic ductal adenocarcinoma (including IPMN malignant transformation, acinar carcinoma, etc., excluding adenosquamous cell carcinoma and neuroendocrine carcinoma)
- The clinical stage is stage III (locally advanced pancreatic cancer), and no radical surgery has been performed (bypass surgery is acceptable), or the patient has resectable pancreatic cancer, but cannot accept surgery or refuse surgery due to physical strength or concomitant diseases
Key exclusion criteria (6 listed)
- Accompanied by malignant tumors of other systems
- Received any form of anti-tumor therapy before treatment, including systemic chemotherapy, interventional chemotherapy, high-energy focused ultrasound, radiotherapy, immunotherapy, molecular targeted therapy, and anti-tumor traditional Chinese medicine therapy
- Have used any other non-anti-tumor research drugs within 4 weeks before treatment
- Combined with uncontrollable hypertension, diabetes, infection, etc.
- Poor compliance, unable or unwilling to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1-year survival rate
Time frame: From the date of first therapy administration to one year later
To observe whether the 1-year survival rate of elderly patients with locally advanced pancreatic cancer treated with sandwich-like chemoradiotherapy modality was comparable to that of the historical data of the general adult population.
6 secondary outcomes
Toxicity and side effects and tolerability assessment
Time frame: From the date of first therapy administration to within 90 days, up to 24 months
event-free survival throughout the enrolled subject population
Time frame: From the date of first therapy administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
the proportion of participants that completed chemoradiotherapy
Time frame: From the date of first enrollment to the date of completion of follow-up of the last patient, up to 24 months.
the proportion ofparticipants that completed all planned courses
Time frame: From the date of first enrollment to the date of completion of follow-up of the last patient, up to 24 months.
Objective response rate (ORR) tumor target lesions in the entire subject population all planned courses
Time frame: From the date of first therapy administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Disease control rate (DCR) of tumor target lesions in the entire subject population all planned courses
Time frame: From date of first therapy administration until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unresectable Locally Advanced Pancreatic Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenquan Wang (+86 21 31587861, wang.wenquan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year survival rate (time frame: From the date of first therapy administration to one year later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.